Florida Senate - 2019                                    SB 1528
       By Senator Bean
       4-02077-19                                            20191528__
    1                        A bill to be entitled                      
    2         An act relating to prescription drug importation
    3         programs for public programs; creating s. 381.02035,
    4         F.S.; establishing the Canadian Prescription Drug
    5         Importation Program within the Agency for Health Care
    6         Administration for a specified purpose; providing
    7         definitions; requiring the agency to contract with a
    8         vendor to facilitate wholesale prescription drug
    9         importation under the program; providing
   10         responsibilities for the vendor; providing eligibility
   11         criteria for prescription drugs, Canadian suppliers,
   12         and importers under the program; requiring
   13         participating Canadian suppliers and importers to
   14         comply with specified federal requirements for
   15         distributing prescription drugs imported under the
   16         program; prohibiting Canadian suppliers and importers
   17         from distributing, dispensing, or selling prescription
   18         drugs imported under the program outside of the state;
   19         requiring the agency to request federal approval of
   20         the program; providing requirements for such request;
   21         requiring the agency to begin operating the program
   22         within a specified timeframe after receiving federal
   23         approval; requiring the agency, in consultation with
   24         the vendor, to submit an annual report to the Governor
   25         and Legislature by a specified date; providing
   26         requirements for such report; authorizing the agency
   27         to adopt rules; providing an effective date.
   29  Be It Enacted by the Legislature of the State of Florida:
   31         Section 1. Section 381.02035, Florida Statutes, is created
   32  to read:
   33         381.02035 Canadian Prescription Drug Importation Program.—
   34         (1)PROGRAM ESTABLISHED.—The agency shall establish a
   35  program for the importation of safe and effective prescription
   36  drugs from Canada which have the highest potential for cost
   37  savings to the state.
   38         (2)DEFINITIONS.—As used in this section, the term:
   39         (a)“Agency” means the Agency for Health Care
   40  Administration.
   41         (b)“Canadian supplier” means a manufacturer, wholesale
   42  distributor, or pharmacy appropriately licensed or permitted
   43  under Canadian law to manufacture, distribute, or dispense
   44  prescription drugs.
   45         (c)“County health department” means a health care facility
   46  established under part I of chapter 154.
   47         (d)“Department” means the Department of Health.
   48         (e)“Free clinic” means a clinic that delivers only medical
   49  diagnostic services or nonsurgical medical treatment free of
   50  charge to low-income recipients.
   51         (f)“Medicaid pharmacy” means a pharmacy licensed under
   52  chapter 465 which has a Medicaid provider agreement in effect
   53  with the agency and is in good standing with the agency.
   54         (g)“Pharmacist” means a person who holds an active and
   55  unencumbered license to practice pharmacy pursuant to chapter
   56  465.
   57         (h) “Prescription drug” has the same meaning as in s.
   58  499.003.
   59         (i) “Program” means the Canadian Prescription Drug
   60  Importation Program.
   61         (3) IMPORTATION PROCESS.—
   62         (a) The agency shall contract with a vendor to provide
   63  services under the program.
   64         (b) By December 1, 2019, the vendor shall develop, and each
   65  year thereafter shall revise, a Wholesale Prescription Drug
   66  Importation List that identifies the prescription drugs that
   67  have the highest potential for cost savings to the state. In
   68  developing the list, the vendor shall consider, at a minimum,
   69  which prescription drugs will provide the greatest cost savings
   70  to state programs, including prescription drugs for which there
   71  are shortages, specialty prescription drugs, and high-volume
   72  prescription drugs. The agency, in consultation with the
   73  department, shall review the Wholesale Prescription Drug
   74  Importation List every 3 months to ensure that it continues to
   75  meet the requirements of the program and may direct the vendor
   76  to revise the list, as necessary.
   77         (c) The vendor shall identify Canadian suppliers who are in
   78  full compliance with relevant Canadian federal and provincial
   79  laws and regulations and who have agreed to export prescription
   80  drugs identified on the list. The vendor must verify that such
   81  Canadian suppliers meet all of the requirements of the program
   82  and will export prescription drugs at prices that will provide
   83  cost savings to the state. The vendor shall contract with such
   84  eligible Canadian suppliers, or facilitate contracts between
   85  eligible importers and eligible Canadian suppliers, to import
   86  prescription drugs under the program.
   87         (d) The vendor must assist the agency with the annual
   88  report required in subsection (9) and provide any information
   89  requested by the agency for such report.
   90         (4) ELIGIBLE PRESCRIPTION DRUGS.—Eligible importers may
   91  import a prescription drug from an eligible Canadian supplier
   92  if:
   93         (a)The drug meets the United States Food and Drug
   94  Administration’s standards related to safety, effectiveness,
   95  misbranding, and adulteration;
   96         (b) Importing the drug would not violate the patent laws of
   97  the United States;
   98         (c) Importing the drug is expected to generate cost
   99  savings; and
  100         (d) The drug is not:
  101         1. A controlled substance as defined in 21 U.S.C. s. 802;
  102         2. A biological product as defined in 42 U.S.C. s. 262;
  103         3. An infused drug;
  104         4. An intravenously injected drug;
  105         5. A drug that is inhaled during surgery; or
  106         6. A drug that is a parenteral drug, the importation of
  107  which is determined by the United States Secretary of Health and
  108  Human Services to pose a threat to the public health.
  109         (5) ELIGIBLE CANADIAN SUPPLIERS.—A Canadian supplier may
  110  export prescription drugs into this state under the program if
  111  the supplier is:
  112         (a) In full compliance with relevant Canadian federal and
  113  provincial laws and regulations; and
  114         (b) Identified by the vendor as eligible to participate in
  115  the program.
  116         (6) ELIGIBLE IMPORTERS.—The following entities may import
  117  prescription drugs from a Canadian supplier under the program:
  118         (a) A pharmacist or wholesaler employed by or under
  119  contract with the department’s central pharmacy, for
  120  distribution to a county health department or free clinic for
  121  dispensing to clients treated in such department or clinic.
  122         (b) A pharmacist or wholesaler employed by or under
  123  contract with a Medicaid pharmacy, for dispensing to the
  124  pharmacy’s Medicaid recipients.
  125         (c) A pharmacist or wholesaler employed by or under
  126  contract with the Department of Corrections, for dispensing to
  127  inmates in the custody of the Department of Corrections.
  128         (d) A pharmacist or wholesaler employed by or under
  129  contract with a developmental disabilities center, as defined in
  130  s. 393.063, for dispensing to clients treated in such center.
  131         (e) A pharmacist or wholesaler employed by or under
  132  contract with a treatment facility, as defined in s. 394.455,
  133  for dispensing to patients treated in such facility.
  134         (7) DISTRIBUTION REQUIREMENTS.—Eligible Canadian suppliers
  135  and importers participating under the program:
  136         (a) Shall comply with the tracking and tracing requirements
  137  of 21 U.S.C. ss. 360eee et seq.; and
  138         (b) May not distribute, dispense, or sell prescription
  139  drugs imported under the program outside of the state.
  140         (8) FEDERAL APPROVAL.—By July 1, 2020, the agency shall
  141  submit a request to the United States Secretary of Health and
  142  Human Services for approval of the program under 21 U.S.C. s.
  143  384(l). The agency shall begin operating the program within 6
  144  months after receiving such approval. The request must, at a
  145  minimum:
  146         (a) Describe the agency’s plan for operating the program;
  147         (b) Demonstrate how the prescription drugs imported into
  148  the state under the program will meet the applicable federal and
  149  state standards for safety and effectiveness;
  150         (c) Include a list of prescription drugs that have the
  151  highest potential for cost savings to the state through
  152  importation at the time that the request is submitted;
  153         (d) Estimate the total cost savings attributable to the
  154  program; and
  155         (e) Include a list of potential Canadian suppliers from
  156  which the state would import prescription drugs and demonstrate
  157  that the suppliers are in full compliance with relevant Canadian
  158  federal and provincial laws and regulations.
  159         (9) ANNUAL REPORTING.—By December 1 of each year, the
  160  agency shall submit a report to the Governor, the President of
  161  the Senate, and the Speaker of the House of Representatives on
  162  the operation of the program during the previous fiscal year.
  163  The report must include, at a minimum:
  164         (a) A list of the prescription drugs that were imported
  165  under the program;
  166         (b) The number of participating entities;
  167         (c) The number of prescriptions dispensed through the
  168  program;
  169         (d) The estimated cost savings during the previous fiscal
  170  year and to date;
  171         (e) A description of the methodology used to determine
  172  which prescription drugs should be included on the Wholesale
  173  Prescription Drug Importation List; and
  174         (f) Documentation demonstrating how the program ensures
  175  that:
  176         1. Canadian suppliers participating in the program are of
  177  high quality, of high performance, and in full compliance with
  178  relevant Canadian federal and provincial laws and regulations;
  179         2. Prescription drugs imported under the program are not
  180  shipped, sold, or dispensed outside of the state once in the
  181  possession of the importer;
  182         3. Prescription drugs imported under the program are pure,
  183  unadulterated, potent, and safe;
  184         4. The program does not put consumers at a higher health
  185  and safety risk than if the program did not exist; and
  186         5. The program provides cost savings to the state on
  187  imported prescription drugs.
  188         (10) RULEMAKING AUTHORITY.—The agency may adopt rules to
  189  implement this section.
  190         Section 2. This act shall take effect July 1, 2019.